Aryx Therapeutics Inc (ARYX)

ARYX»Topics» If our preclinical studies do not produce successful results or our clinical trials do not demonstrate safety and efficacy in humans, we will not be able to commercialize our product candidates.

If our preclinical
studies do not produce successful results or our clinical trials do not
demonstrate safety and efficacy in humans, we will not be able to commercialize
our product candidates.

To obtain the requisite regulatory approvals
to market and sell any of our product candidates, we must demonstrate, through
extensive preclinical studies and clinical trials, that the product candidate
is safe and effective in humans. To date, we have not completed all required
clinical trials of any product candidate. Preclinical and clinical testing is
expensive, can take many years and has an uncertain outcome. A failure of one
or more of our clinical trials could occur at any stage of testing. In
addition, success in preclinical testing and early clinical trials does not
ensure that later clinical trials will be successful, and interim results of a
clinical trial do not necessarily predict final results. We may experience
numerous unforeseen events during, or as a result of, preclinical testing and
the clinical trial process, which could delay or prevent our ability to
commercialize our product candidates, including:

·regulators
or institutional review boards may not authorize us to commence a clinical
trial at a prospective trial site;

·our
preclinical studies or clinical trials may produce negative or inconclusive
results, which may require us to conduct additional preclinical or clinical
testing or to abandon development projects;

·we
may suspend or terminate our clinical trials if the participating patients are
being exposed to unacceptable health risks;

·regulators
or institutional review boards may suspend or terminate clinical research for
various reasons, including noncompliance with regulatory requirements;

·the
effects of our product candidates may not be the desired effects or may include
undesirable side effects; and

·our
preclinical studies or clinical trials may show that our product candidates are
not superior to the original drugs on which our product candidates are modeled.

For instance, our preclinical studies and
clinical trials may indicate that our product candidates cause unexpected
drug-drug interactions and result in adverse events. As another example,
additional clinical trials of tecarfarin will be necessary in order to demonstrate
clinical superiority to warfarin. Even if we adequately demonstrate that
tecarfarin is safe and effective and obtain FDA approval, we may not be
permitted to market it as superior to warfarin. In addition, budiodarones
preclinical studies contain results that are currently being monitored in the
clinic. Inhibition of testicular function was observed in one animal species as
part of these studies. No such effect has been observed to date in the clinic
and monitoring continues. In published studies, a similar effect is thought to
be correlated with the accumulation of amiodarone in tissues. A possible renal
effect was also observed at high doses in our rat and dog toxicology studies
for budiodarone. While we will continue to monitor patients for these effects,
there is no assurance these effects will not occur in patients as part of our
ongoing and planned clinical trials for budiodarone, and have a resulting
adverse effect on our ability to obtain requisite regulatory approval to market
and sell budiodarone. Similarly, in the clinical testing of budiodarone in
patients whose condition also required treatment with warfarin, dose
adjustments of warfarin were sometimes required. As is common to most clinical
trials, the potential for drug-drug interactions will be monitored. In a canine
toxicology study of ATI-7505 performed by our former collaboration partner,
P&G, six deaths occurred at doses that were 10 and 20 times greater than
doses currently being used in clinical trials. Our clinical trials to date have
indicated only mild to moderate side effects in humans. However, further
observation is warranted.

Even when our product candidates do not cause
any adverse effects, clinical studies of efficacy may show that our product
candidates do not have significant effects on target symptoms or may be
inconclusive. For example, ATI-7505 was tested in two Phase 2 clinical
trials in which the primary endpoints were not met in comparison to placebo.
Although these studies did support ATI-7505s efficacy against certain symptoms
as secondary endpoints, if future studies show that ATI-7505 is not
sufficiently efficacious to justify its use as a therapy, our business and
prospects may be materially adversely affected. In addition, we may need to
reformulate the ATI-9242 drug product should we find in our on-going
Phase 1 testing that adequate blood levels are not achieved with our
current formulation.

Unforeseen events could cause us to
experience significant delays in, or the termination of, clinical trials. Any
such events would increase our costs and could delay or prevent our ability to
commercialize our product candidates, which would adversely impact our
financial results.

If our preclinical studies do not produce successful results or our clinical trials do not demonstrate safety and efficacy in humans, we will not be able to commercialize
our product candidates.

To obtain the requisite regulatory approvals to market and sell any of our product candidates, we must demonstrate, through extensive
preclinical studies and clinical trials, that the product candidate is safe and effective in humans. To date, we have not completed all required clinical trials of any product candidate. Preclinical
and clinical testing is expensive, can take many years and has an uncertain outcome. A failure of one or more of our clinical trials could occur at any stage of testing. In addition, success in
preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. We may
experience numerous unforeseen events during, or as a result of, preclinical testing and the clinical trial process, which could delay or prevent our ability to commercialize our product candidates,
including:



regulators or institutional review boards may not authorize us to commence a clinical trial at a prospective trial site;



our preclinical studies or clinical trials may produce negative or inconclusive results, which may require us to conduct
additional preclinical or clinical testing or to abandon development projects;



we may suspend or terminate our clinical trials if the participating patients are being exposed to unacceptable health
risks;



regulators or institutional review boards may suspend or terminate clinical research for various reasons, including
noncompliance with regulatory requirements;



the effects of our product candidates may not be the desired effects or may include undesirable side effects; and



our preclinical studies or clinical trials may show that our product candidates are not superior to the original drugs on
which our product candidates are modeled.

For
instance, our preclinical studies and clinical trials may indicate that our product candidates cause unexpected drug-drug interactions and result in adverse events. As
another example, additional clinical trials of tecarfarin will be necessary in order to demonstrate clinical superiority to warfarin. Even if we adequately demonstrate that tecarfarin is safe and
effective and obtain FDA approval, we may not be permitted to market it as superior to warfarin. In addition, budiodarone's preclinical studies contain results that are currently being monitored in
the clinic. Inhibition of testicular function was observed in one animal species as part of these studies. No such effect has been observed to date in the clinic and monitoring continues. In published
studies, a similar effect is thought to be correlated with the accumulation of amiodarone in tissues. A possible renal effect was also observed at high doses in our rat and dog toxicology studies for
budiodarone. While we will continue to monitor patients for these effects, there is no assurance these effects will not occur in patients as part of our ongoing and planned clinical trials for
budiodarone, and have a resulting adverse effect on our ability to obtain requisite regulatory approval to market and sell budiodarone. Similarly, in the clinical testing of budiodarone in patients
whose condition also required treatment with warfarin, dose adjustments of warfarin were sometimes required. As is common to most clinical trials, the potential for drug-drug interactions will be
monitored. In a canine toxicology study of ATI-7505 performed by our former collaboration partner, P&G, six deaths occurred at doses that were 10 and 20 times greater than doses currently
being used in clinical trials. Our clinical trials to date have indicated only mild to moderate side effects in humans. However, further observation is warranted.

Even
when our product candidates do not cause any adverse effects, clinical studies of efficacy may show that our product candidates do not have significant effects on target symptoms or
may be inconclusive. For example, ATI-7505 was tested in two Phase 2 clinical trials in which the primary endpoints were not met in comparison to placebo. Although these studies did
support ATI-7505's efficacy against certain symptoms as secondary endpoints, if future studies show that ATI-7505 is not sufficiently efficacious to justify its use as a
therapy, our business and prospects may be materially adversely affected. In addition, we may need to reformulate the ATI-9242 drug product should we find in our on-going
Phase 1 testing that adequate blood levels are not achieved with our current formulation.

Unforeseen
events could cause us to experience significant delays in, or the termination of, clinical trials. Any such events would increase our costs and could delay or prevent our
ability to commercialize our product candidates, which would adversely impact our financial results.

If our preclinical studies do not produce
successful results or our clinical trials do not demonstrate safety and
efficacy in humans, we will not be able to commercialize our product
candidates.

To
obtain the requisite regulatory approvals to market and sell any of our product
candidates, we must demonstrate, through extensive preclinical studies and
clinical trials, that the product candidate is safe and effective in humans. To
date, we have not completed the clinical trials of any product candidate.
Preclinical and clinical testing is expensive, can take many years and has an
uncertain outcome. A failure of one or more of our clinical trials could occur
at any stage of testing. In addition, success in preclinical testing and early
clinical trials does not ensure that later clinical trials will be successful,
and interim results of a clinical trial do not necessarily predict final
results. We may experience numerous unforeseen events during, or as a result
of, preclinical testing and the clinical trial process, which could delay or
prevent our ability to commercialize our product candidates, including:

·regulators or institutional review boards may not authorize us to
commence a clinical trial at a prospective trial site;

·our preclinical studies or clinical trials may produce negative or
inconclusive results, which may require us to conduct additional preclinical or
clinical testing or to abandon development projects;

·we may suspend or terminate our clinical trials if the participating
patients are being exposed to unacceptable health risks;

·regulators or institutional review boards may suspend or terminate
clinical research for various reasons, including noncompliance with regulatory
requirements;

·the effects of our product candidates may not be the desired effects or
may include undesirable side effects; and

·our preclinical studies or clinical trials may show that our product
candidates are not superior to the original drugs on which our product
candidates are modeled.

For
instance, our preclinical studies and clinical trials may indicate that our
product candidates cause unexpected drug-drug interactions and result in
adverse events. As another example, more extensive and robust clinical trials
of ATI-5923 will be necessary in order to demonstrate clinical superiority to
warfarin. Even if we adequately demonstrate that ATI-5923 is safe and effective
and obtain FDA approval, we may not be permitted to market it as superior to
warfarin. In addition, ATI-2042s preclinical studies contain results that are
currently being monitored in the clinic. Inhibition of testicular function was
observed in one animal species as part of these studies. No such effect has
been observed to date in the clinic and monitoring continues. In published
studies, a similar effect is thought to be correlated with the accumulation of
amiodarone in tissues. A

possible renal effect was
also observed at high doses in our rat and dog toxicology studies for ATI-2042.
While we will continue to monitor patients for these effects, there is no
assurance these effects will not occur in patients as part of our ongoing and
planned clinical trials for ATI-2042, and have a resulting adverse effect on
our ability to obtain requisite regulatory approval to market and sell
ATI-2042. In a canine toxicology study of ATI-7505 performed by our former
collaboration partner, P&G, six deaths occurred at doses that were 10 and
20 times greater than doses currently being used in clinical trials. Our
clinical trials to date have indicated only mild to moderate side effects in
humans. However, further observation is warranted.

Even
when our product candidates do not cause any adverse effects, clinical studies
of efficacy may show that our product candidates do not have significant
effects on target symptoms or may be inconclusive. For example, ATI-7505 was
tested in two Phase 2 clinical trials in which the primary endpoints were
not met in comparison to placebo. Although these studies did support ATI-7505s
efficacy against certain symptoms as secondary endpoints, if future studies
show that ATI-7505 is not sufficiently efficacious to justify its use as a
therapy, our business and prospects may be materially adversely affected.

Unforeseen
events could cause us to experience significant delays in, or the termination
of, clinical trials. Any such events would increase our costs and could delay
or prevent our ability to commercialize our product candidates, which would
adversely impact our financial results.

If our
preclinical studies do not produce successful results or our clinical trials do
not demonstrate safety and efficacy in humans, we will not be able to
commercialize our product candidates.

To obtain the requisite regulatory approvals to
market and sell any of our product candidates, we must demonstrate, through
extensive preclinical studies and clinical trials, that the product candidate
is safe and effective in humans. To date, we have not completed the clinical trials
of any product candidate. Preclinical and clinical testing is expensive, can
take many years and has an uncertain outcome. A failure of one or more of our
clinical trials could occur at any stage of testing. In addition, success in
preclinical testing and early clinical trials does not ensure that later
clinical trials will be successful, and interim results of a clinical trial do
not necessarily predict final results. We may experience numerous unforeseen
events during, or as a result of, preclinical testing and the clinical trial
process, which could delay or prevent our ability to commercialize our product
candidates, including:

regulators or institutional review boards may
not authorize us to commence a clinical trial at a prospective trial site;

our preclinical studies or clinical trials
may produce negative or inconclusive results, which may require us to conduct
additional preclinical or clinical testing or to abandon development projects;

we may suspend or terminate our clinical
trials if the participating patients are being exposed to unacceptable health
risks;

regulators or institutional review boards may
suspend or terminate clinical research for various reasons, including
noncompliance with regulatory requirements;

the effects of our product candidates may not
be the desired effects or may include undesirable side effects; and

our preclinical studies or clinical trials
may show that our product candidates are not superior to the original drugs on
which our product candidates are modeled.

For instance, our preclinical studies and clinical
trials may indicate that our product candidates cause unexpected drug-drug
interactions and result in adverse events. As another example, more extensive
and robust clinical trials of ATI-5923 will be necessary in order to
demonstrate clinical superiority to warfarin. Even if we adequately demonstrate
that ATI-5923 is safe and effective and obtain FDA approval, we may not be
permitted to market it as superior to warfarin. In addition, ATI-2042s
preclinical studies contain results that are currently being monitored in the
clinic. Inhibition of testicular function was observed in one animal species as
part of these studies. No such effect has been observed to date in the clinic
and monitoring continues. In published studies, a similar effect is thought to
be correlated with the accumulation of amiodarone in tissues. A possible renal
effect was also observed at high doses in our rat and dog toxicology studies
for ATI-2042. While we will continue to monitor patients for these effects,
there is no assurance these effects will not occur in patients as part of our
ongoing and planned clinical trials for ATI-2042, and have a resulting adverse
effect on our ability to obtain requisite regulatory approval to market and
sell ATI-2042. In a canine toxicology study of ATI-7505 performed by our former
collaboration partner, P&G, six deaths occurred at doses that were 10 and
20 times greater than doses currently being used in clinical trials. Our
clinical trials to date have indicated only mild to moderate side effects in
humans. However, further observation is warranted.

Even when our product candidates do not cause any
adverse effects, clinical studies of efficacy may show that our product
candidates do not have significant effects on target symptoms or may be
inconclusive. For example, ATI-7505 was tested in two Phase 2 clinical
trials in which the primary endpoints were not met in comparison to placebo.
Although these studies did support ATI-7505s efficacy against certain symptoms
as secondary endpoints, if future studies show that ATI-7505 is not
sufficiently efficacious to justify its use as a therapy, our business and
prospects may be materially adversely affected.

Unforeseen events could cause us to experience
significant delays in, or the termination of, clinical trials. Any such events
would increase our costs and could delay or prevent our ability to
commercialize our product candidates, which would adversely impact our
financial results.

If our preclinical studies do not produce
successful results or our clinical trials do not demonstrate safety and
efficacy in humans, we will not be able to commercialize our product
candidates.

To obtain the
requisite regulatory approvals to market and sell any of our product
candidates, we must demonstrate, through extensive preclinical studies and
clinical trials, that the product candidate is safe and effective in humans. To
date, we have not completed the clinical trials of any product candidate.
Preclinical and clinical testing is expensive, can take many years and has an
uncertain outcome. A failure of one or more of our clinical trials could occur
at any stage of testing. In addition, success in preclinical testing and early
clinical trials does not ensure that later clinical trials will be successful,
and interim results of a clinical trial do not necessarily predict final
results. We may experience numerous unforeseen events during, or as a result
of, preclinical testing and the clinical trial process, which could delay or
prevent our ability to commercialize our product candidates, including:

·regulators or institutional review boards may not
authorize us to commence a clinical trial at a prospective trial site;

·our preclinical studies or clinical trials may produce
negative or inconclusive results, which may require us to conduct additional
preclinical or clinical testing or to abandon development projects;

·we may suspend or terminate our clinical trials if the
participating patients are being exposed to unacceptable health risks;

·regulators or institutional review boards may suspend
or terminate clinical research for various reasons, including noncompliance
with regulatory requirements;

31

·the effects of our product candidates may not be the
desired effects or may include undesirable side effects; and

·our preclinical studies or clinical trials may show
that our product candidates are not superior to the original drugs on which our
product candidates are modeled.

For instance, our
preclinical studies and clinical trials may indicate that our product
candidates cause unexpected drug-drug interactions and result in adverse
events. As another example, more extensive and robust clinical trials of
ATI-5923 will be necessary in order to demonstrate clinical superiority to
warfarin. Even if we adequately demonstrate that ATI-5923 is safe and effective
and obtain FDA approval, we may not be permitted to market it as superior to
warfarin. In addition, ATI-2042s preclinical studies contain results that are
currently being monitored in the clinic. Inhibition of testicular function was
observed in one animal species as part of these studies. No such effect has
been observed to date in the clinic and monitoring continues. In published
studies, a similar effect is thought to be correlated with the accumulation of
amiodarone in tissues. A possible renal effect was also observed at high doses
in our rat and dog toxicology studies for ATI-2042. While we will continue to
monitor patients for these effects, there is no assurance these effects will
not occur in patients as part of our ongoing and planned clinical trials for
ATI-2042, and have a resulting adverse effect on our ability to obtain
requisite regulatory approval to market and sell ATI-2042. In an ongoing canine
toxicology study of ATI-7505 being performed by P&G, six deaths occurred at
doses that were 10 and 20 times greater than doses currently being used in
clinical trials. Our clinical trials to date have indicated only mild to
moderate side effects in humans. However, further observation is warranted.

Even when our
product candidates do not cause any adverse effects, clinical studies of
efficacy may show that our product candidates do not have significant effects
on target symptoms or may be inconclusive. For example, ATI-7505 was tested in
two Phase 2 clinical trials in which the primary endpoints were not met in
comparison to placebo. Although these studies did support ATI-7505s efficacy
against certain symptoms as secondary endpoints, if future studies show that
ATI-7505 is not sufficiently efficacious to justify its use as a therapy, our
business and prospects will be materially adversely affected.

Unforeseen events
could cause us to experience significant delays in, or the termination of,
clinical trials. Any such events would increase our costs and could delay or
prevent our ability to commercialize our product candidates, which would
adversely impact our financial results.